Zotepine

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Habermann (Control exposed to FGA), 2013 Germany
1997 - 2009
Subjects were enrolled through the consultation process at Teratology Information Service (TIS Berlin) Women exposed to Zotepine during pregnancy; comedication with First Generation Antipsycotics (FGA) was allowed. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Women exposed to First Generation Antipsychotics (FGAs) excluding comedication with Second Generation Antipsychotics (SGA) (cohort I).
2 / 284 Primary analyse on all Atypical Antipsychotics but Raw data are provided for some substances. Cases with potentially embryo- or fetotoxic drugs were not excluded for both the study cohort and the comparison cohort I but were assessed afterward.
Habermann (Control unexposed, disease free), 2013 Germany
1997 - 2009
Subjects were enrolled through the consultation process at Teratology Information Service (TIS Berlin) Women exposed to Zotepine during pregnancy; comedication with First Generation Antipsycotics (FGA) was allowed. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Women exposed to teratogenic, fetotoxic, or insufficiently studied agents were excluded as described elsewhere (cohort II).
2 / 1122 Primary analyse on all Atypical Antipsychotics but Raw data are provided for some substances. Cases with potentially embryo- or fetotoxic drugs were not excluded for both the study cohort and the comparison cohort I but were assessed afterward.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol